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GE Drops Omniscan Libel Suit

GE Healthcare has dropped a libel suit it filed in the United Kingdom (UK) against a Danish researcher who had who warned its gadolinium contrast dye was associated with nephrogenic systemic fibrosis (NSF) in 2007. When GE Healthcare sued Henrik Thomsen, it was speculated that the company was trying to stifle criticism of Omniscan.

Gadolinium contrast dyes are used to enhance images during MRI, and sometimes MRA, procedures. NSF is a rare, debilitating and often fatal disease that appears to only affect people with severe kidney disease who have been exposed to these products. In the U.S., Omniscan and all other gadolinium dyes currently in use have been required to bear a black box warning regarding the potential for NSF since 2007, and the Food & Drug Administration (FDA) is currently considering even tougher labeling requirements for the drugs.

As we’ve reported previously, Thomsen began speaking out about NSF and its association with gadolinium dyes after about 30 patients at Copenhagen University Hospital developed the condition. GE Healthcare’s libel suit alleges that Thomsen claimed the company marketed Omniscan despite knowing about its adverse side-effects; suppressed the information and concealed it from radiologists; and exposed patients who were administered Omniscan to the danger of NSF. GE Healthcare alleged the defamation occurred during a 15-minute presentation Thomas made to fellow radiologists in 2007 at Oxford University, and in statements made in an article published in Thomsenâ€™s name in the journal Imaging Management.

In a press release announcing its settlement with Thomsen, GE Healthcare said it was not its intention to stifle academic debate. The company said it objected to statements made by Thomsen which it interpreted as suggesting that it had known from the outset that Omniscan caused NSF. The company said it now accepts his concerns were expressed in good faith.

In the same press release, Thomsen said: “I stand by my publicly expressed opinion, based on my experience and research on published papers, that there is an association between the chemical formulation of gadolinium-based contrast agents and NSF.”

“It was not my intention to suggest on the basis of the evidence then available to me that GE Healthcare had marketed Omniscan knowing that it might cause NSF, ” he added.

According to the UK Guardian, the terms of GE Healthcare’s settlement with Thomsen have not been revealed.

Omniscan and the other gadolinium dyes currently on the market have already been named in over 500 U.S. lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the agents.. Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio.